Device recall
Z-0277-05: OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test…
FDA device recall · Class II · Chembio Diagnostic System Inc
Key facts
| Recall number (Z-number) | Z-0277-05 |
|---|---|
| Recall event | 30288 |
| Product | OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check… |
| Product code | LCX |
| Recalling firm | Chembio Diagnostic System Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2005 |
| 510(k) numbers | K933529 |
| FEI number | 2431980 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database